Job DescriptionSalary
Critical Mass Consulting, LLC is seeking individuals who want to learn and develop within a dynamic, start-up environment. We believe in our purpose:To develop a company which thrives on connectivity and engagement; to build a premier consulting organization, which rewards creativity, contribution and growth.
Critical Mass Consulting, LLC is supporting Life Sciences clients in the areas of:
- Process Engineering
- Project Management
- Equipment, Utility and Facility Start-Up and Commissioning/Qualification
- Validation Program Development
- Tech Transfer, Process Engineering and Validation
- Cleaning / Sterilization Validation
- Computerized System Validation (CSV)
Our company places an emphasis on continuous personal development. This includes support/financing of technical training, mentorship, and development of high performance teams.
Job Description
Critical Mass Consulting, LLC is recruiting a Process Engineer to join its Vacaville, CA field office. If you have a passion for Life Sciences and helping others, we are interested in discussing our company, our process and what it means to join our team-focused organization.
Process Engineering Scope
- Lead and support high-paced engineering activities for complex drug-substance manufacturing and equipment readiness programs, including coordination across process systems, equipment vendors, construction partners, and automation teams.
- Lead and support Tech Transfer and Design of Purification manufacturing systems.
- Provide day-to-day technical leadership during equipment design, installation, start-up, and commissioning activities, ensuring systems align with design documents, user requirements, and cGMP expectations.
- Manage and support process engineering and system lifecycle activities, including:
- System procurement and vendor coordination
- Generation and review of Validation Master Plan documentation (URS, FRS, Design Qualification) for standard equipment and custom-built systems
- FAT/SAT, IOQ/PQ execution and oversight
- Support system receipt verifications, automation loop testing, equipment startup, facility and utilities readiness, and mechanical completion activities, ensuring proper commissioning, testing, and hand-over to end users.
- Serve as the technical representative of the process engineering team, supporting project manager(s) and providing on-site expertise during critical phases of execution.
- Conduct a thorough review of P&ID and electrical schematics and perform walk-downs, identify gaps or issues, and drive collaborative resolution in a timely and compliant manner.
- Provide on-the-floor troubleshooting and SME level support for systems and processes, ensuring timely resolution of issues through. collaboration with internal teams, vendors, and external stakeholders.
- Lead proactive vendor management activities to ensure timely deliverables, clear communication, and alignment with project requirements.
- Review and verify the accuracy of Turnover Packages (TOPs) in alignment with approved SOPs and cGMP requirements.
- Track and document issues in an organized, transparent manner to provide visibility to project stakeholders and drive timely closure.
- Manage and oversee document workflows within paperless validation/documentation systems. Experience with VEEVA or Master control, paperless validation systems such as Kneat or ValGenesis is a strong plus.
- Support deviation management, vendor document control, and change request workflows to maintain accurate and compliant project documentation.
- Coordinate closely with automation engineering partners to ensure control system design, installation, and IOQ activities are aligned with equipment requirements and project timelines.
- Provide mentorship and training to junior engineers, sharing technical expertise, best practices, and guidance to strengthen team capabilities and ensure consistent project execution standards.
General Consulting Responsibilities
- Build and maintain strong, trust-based relationships with clients, acting as a reliable SME and strategic partner throughout project execution.
- Demonstrate dynamic problem-solving and critical thinking skills to provide clients with practical, risk-based solutions that balance compliance, efficiency, and innovation.
Required Qualifications
- Belief in our Core Values. These 4 values provide the foundation for how we operate as a company. With these common shared values, we can effectively accomplish our mission of organizational excellence.
- People Come First
- We Build Together
- Empowering Growth and Leading People to Make a Difference
- Joy and Discipline, Life in Balance
- 4+ years of relevant engineering experience in the Life Sciences industries.
- A passion for Life Sciences and helping others.
- Excellentwritten and verbal communication skills.
- Strong competency in using Project Management tools.
- Proficient in Microsoft Office Suite (MS Word and MS Excel).
Preferred Experience
- Experience with plant shutdown projects
- Experience with commissioning and/or decommissioning of process equipment and utility systems
- Experience with upstream and downstream process equipment
- 4-8 years of experience Project experience in pharmaceutical,medical device or biotech industry.
Salary: USD 72000 - 108000 per year
